A day ahead of the launch of massive nationwide vaccination drive against the Covid-19, the centre has now come up with new safety regulations saying Bharat Biotech’s Covaxin vaccine will not be administered to people below 18 years of age.
According to the reports, a letter from the office of additional secretary at the union health ministry carrying a comparative factsheet for the two approved vaccines under emergency authorisation rules revealed that the government has “not recommended” their authorisation to people below 18 years of age.
Earlier, it was approved for children above the age of 12 years by the Drugs Controller General of India (DCGI). The DCGI, after approving Bharat Biotech’s Covaxin for EUA, had allowed its authorisation to children above 12 years of age. Similarly, another Corona vaccine, Covishield developed by Serum Institute of India (SII), was permitted to people above 18 years of age.
However, the CDSCO officials have now clarirfied that the earlier provision was soon withdrawn and revised by the drug licensing authority. The officials said this certain condition approved for Covaxin was flagged to the drug regulatory authority and soon it was rebuked.
“We were flagged about the provision and soon it was revised with a condition that the vaccines would only be administered to beneficiaries above 18 years of age,” a senior official said.
No interchangeability of vaccine, pregnant women will not be administered vaccine: Health Ministry
Meanwhile, the Health Ministry on Thursday said that interchangeability of COVID-19 vaccines will not be permitted and the second dose of the vaccine inoculated should be the same vaccine injected as the first dose.
In a letter to all states and Union territories, the Health Ministry also stated that under the emergency use authorisation, coronavirus vaccination is indicated only for 18 years and above. If required, COVID-19 vaccine and other vaccines should be separated by an interval of at least 14 days.
“Interchangeability of COVID-19 vaccines is not permitted. The second dose should also be of the same COVID-19 vaccine which was administered as the first dose,” the letter written to states said.
Addition to that, pregnant and lactating women will also not be administered the shots as they have not been part of any anti-coronavirus vaccine clinical trial so far, the health ministry said.
“Pregnant and lactating women have not been a part of any COVID-19 vaccine clinical trial so far. Therefore, women who are pregnant or not sure of their pregnancy and lactating women should not receive COVID-19 vaccine at this time,” the letter stated.
The ministry has also listed precautions and contraindications for Covid vaccination along with a comparative factsheet for both the vaccines (Covishield and Covaxin) which contains information on vaccine platform, physical specifications, dosage, cold-chain storage requirements, contraindications and minor AEFIs (adverse event following immunization).
The Health Ministry has advised states to disseminate information to programme managers across all levels and through them to cold-chain handlers and vaccinators for ready reference.
Health Ministry asks to follow proper protocol, issues caution
Listing the contraindications, the Health Ministry also cautioned against the administration of the vaccine in persons with a history of an anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine.
According to the letter, in case of persons having active symptoms of SARS-CoV-2 infection, coronavirus infected patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma and acutely unwell and hospitalised patients due to any illness, the COVID-19 vaccination is to be deferred for four to eight weeks after recovery.
The vaccine should be administered with caution in persons with a history of any bleeding or coagulation disorder (like clotting factor deficiency, coagulopathy or platelet disorder, it said.
“Following conditions are not contraindicated for COVID-19 vaccines: persons with past history of SARS-CoV-2 infection and or RT-PCR positive illness, history of chronic diseases and morbidities and immuno-deficiency, HIV, patients on immune suppression due to any condition,” the letter stated.
Prime Minister Narendra Modi will launch India’s massive Covid-19 vaccination drive on January 16 via video conferencing. The centre has delivered adequate doses of Bharat Biotech’s ‘Covaxin’ and Serum Institute’s ‘Covishield’ vaccines to all states and Union territories ahead of the vaccination drive.